This 3-Hour course clarifies how to classify cloud systems with precision, using CSA thinking to prevent wasted effort and hidden compliance risks. It strengthens judgment so teams validate what matters and avoid the traps that undermine inspection readiness.
Why This Training Matters
Classification mistakes are one of the biggest reasons cloud validation efforts fall apart. Teams often rely on legacy CSV thinking when systems demand sharper, risk-driven judgment. Digital Validation and Cloud Assurance helps teams assess intended use, GxP relevance, and critical workflows without drowning in unnecessary documentation. Misreading complexity or misunderstanding shared responsibility leads to weak audit defences and data integrity gaps. By anchoring early decisions in Computer Software Assurance principles and risk-based validation, companies can avoid costly missteps. Digital Validation and Cloud Assurance provide a clear, modern way to classify cloud systems before validation begins - and sets the tone for everything that follows.Course Content
- FDA’s shift from CSV → CSA
- Identifying GxP systems in modern digital/cloud environments
- Intended Use
- Risk assessment (complexity, criticality, GAMP 5, failure risk)
- CSV foundation (requirements → design → testing → release)
- Why CSV fails in cloud environments
- DI basics (ALCOA+++, raw data integrity)
- Introduction to Shared Responsibility
Speaker
Carolyn Troiano brings decades of real-world validation leadership across pharma, medical devices, biotech, and other FDA-regulated sectors. She helped shape early CSV approaches, contributed to 21 CFR Part 11 discussions, and has guided global companies through complex system implementations. Her style is practical, clear, and rooted in hands-on experience with modern cloud and CSA expectations.Who Should Attend
- Quality Assurance (QA)
- Quality Control (QC)
- Regulatory Affairs (RA)
- Validation / Computerized System Validation (CSV)
- Information Technology / Information Systems (IT/IS)
- Cloud Engineering and Automation Teams
- Manufacturing and Production Leadership
- Data Governance and Data Integrity Teams
- R&D and Digital Development Teams
- Lab Informatics and LIMS/ELN Administrators
- Compliance, Audit, and Inspection Readiness Teams
- Design and Software Development Engineers
